Case Study: Adverse Drug Reactions

The patient is a 59-year-old male with Type 2 diabetes, hyperlipidemia, and hypertension. He has no history of liver disease.

Background:

• Started Drug X on Feb 11, 2016
• Other medications: simvastatin and lisinopril
• Labs drawn on Feb 11 revealed liver enzymes, INR, creatinine, and bilirubin all within normal limits
• No alcohol use
• 8 weeks after starting Drug X, patient presented to ER with 5-day history of jaundice, dark urine, and nausea/vomiting
• He was admitted to ICU and subsequently diagnosed with acute liver failure
• Drug X stopped upon admission
• Viral hepatitis was ruled out
• 7 days after stopping the medication, all lab values returned to normal

1. List two reasons why this patient may be at risk for an adverse event.

2. Is a temporal relationship of acute liver failure with drug X reported in this case?
Yes or No